Plain English Summary

Background and study aims Approximately one child in 500-600 is born with a cleft of the lip and/or palate. These arise in the womb when the different components of the lips, the upper jaw and the hard and soft palate fail to complete their growth. One-sided (or unilateral) clefts can include a complete gap in the lip, jaw, and palate. Even with modern surgery to close the cleft, affected children often require lengthy treatment into the late teens to optimise facial and dental appearance, speech, and hearing. The initial surgeries performed in the first year or so of life, are critical in determining the long term outcomes and the need for subsequent treatment. However, there is a great deal of uncertainty and controversy concerning the surgical timing and techniques that should be adopted. The purpose of this study is to compare the success of different surgical techniques for closing complete unilateral clefts of the lip and palate.

Who can participate? Infants attending cleft lip and palate centres in Denmark, Finland, Norway, Sweden, and the UK

What does the study involve? Participants are randomly allocated to one of four groups. Those in group 1 undergo lip and soft palate closure at 3-4 months of age and hard palate closure at 12 months/ Those in group 2 have similar treatment than those in group 1 – they just have their hard palate repair at 36 months. Those in group 3 undergo lip repair at 3-4 months and hard and soft palate closure at 12 months. Those in group 4 have their lip and hard palate repaired at 3-4 months and soft palate repaired at 12 months. Records for each group of participants is collected, which includes short term results of the surgery, the recovery period, the need for further surgery, longer term speech and language development, dental and jaw development, and nose/lip appearance.

What are the possible benefits and risks of participating? Not provided at time of registration

Where is the study run from?A total of 9 Cleft Lip and Palate/ Craniofacial Centres in Denmark, Finland, Norway, Sweden and the UK.

When is the study starting and how long is it expected to run for? September 1997 to September 2024

Who is funding the study? European Commission

Who is the main contact? Professor Gunvor Sembgunvor.semb@manchester.ac.uk

Study design

Primary study design

Secondary study design

Trial setting

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Complete unilateral cleft lip and palate

Intervention

One surgical protocol was defined to serve as a common method in each trial against which the established local protocols were compared. The common surgical protocol was lip and soft palate closure at 3-4 months and hard palate closure at 12 months.

Trial 1: compared this with only a variation in timing: hard palate repair at 36 monthsTrial 2: compared this with lip repair at 3-4 months followed by hard and soft palate closure at 12 monthsTrial 3: compared this with lip and hard palate repair at 3-4 months and soft palate repair at 12 months

The primary outcomes at age 5 were speech and dentofacial development, with a series of perioperative and longer term secondary outcomes.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. Speech and language at age 5 years, via blinded panel assessments using standardised audio/video recordings with regard to consonant proficiency and ratings of velopharyngeal competency and hypernasality2. Dentofacial development at 5 years, via blinded panel ratings of dentofacial relationship represented by articulated plaster casts of the dentition using the Five Year Yardstick and Huddart-Bodenham Index

Secondary outcome measures

1. Perioperative complications recorded by medical and nursing staff2. Operation and hospitalisation time3. Postoperative recovery and feeding recorded by medical and nursing staff4. Speech at 12 and 18 months and 3 years5. Symptomatic fistulae6. Hearing7. Burden of care8. Parent satisfaction at age 5 years

Overall trial start date

01/09/1997

Overall trial end date

01/09/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Caucasian patients born with non-syndromic unilateral complete cleft lip and palate. Patients with a soft tissue bridge (Simonart`s band) could be included as long as the width of the soft tissue bridge was not more than 5mm. The prevailing language of the country where recruited had to be spoken at home.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

450

Participant exclusion criteria

1. Non-caucasian2. Wide Simonart band3. Prevailing local language not spoken at home